Articoli correlati a Validating Corporate Computer Systems: Good IT Practice...

Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers - Brossura

 
9780367398569: Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers
Brossura
ISBN 10: 0367398567 ISBN 13: 9780367398569
Casa editrice: CRC Press, 2019

Sinossi

One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Informazioni sull'autore

Guy Wingate

Dalla quarta di copertina

Written by experts, this book provides authoritative information and practical advice on validating corporate computer systems. It covers good IT practice and validation principles and presents case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include the increasing role of IT systems within the modern pharmaceutical manufacturing plant and the move toward paperless manufacturing, how to develop an information strategy, the importance of demonstrating regulatory compliance, how to maintain validated systems, conduct supplier audits for software packages, hardware manufacturers, and software integrators, the practical implications of 21 CFR 11, and more.

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

Editore
CRC Press
Data di pubblicazione
2019
Lingua
Inglese
ISBN 10 
0367398567
ISBN 13 
9780367398569
Rilegatura
Copertina flessibile
Numero edizione
1
Numero di pagine
544
Redattore
Wingate Guy
Contatto del produttore
non disponibile
Persona responsabile
non disponibile